Status:
COMPLETED
Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included. The sub...
Detailed Description
At baseline, subject characteristics will be registered together with subject status of health and status of the burn, and current treatment of the burn. At each visit the following variables will be...
Eligibility Criteria
Inclusion
- Subject with a small partial thickness burn (\< 9.5x15 cm) where an antimicrobial action is indicated as judged by the investigator\*
- Male or female, 18 years and above, both in- and out-patient subjects
- Signed Informed Consent Form
Exclusion
- Wound size equal to or above 9.5x15cm for the selected burn for the investigation
- Pregnant and/or breastfeeding women
- Subject not expected to follow the investigation procedures or applicable for investigation according to the judgment of the investigator
- Subjects with known sensitivity to silver or any other contents of the dressing
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01418482
Start Date
January 1 2011
End Date
July 1 2011
Last Update
June 5 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Briva/Hpk
Linköping, Sweden
2
Plastikkirurgiska kliniken, UAS BRIVA
Uppsala, Sweden